Quick-Start Orthopaedic Fixation Screw and Reverse Thread Screw
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identifiers
- 510(k) Number
- K242442 FDA 510(k)
- FDA Product Code
- HWC FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 888.3040 FDA 510(k)
- Regulation Number
- 888.3040 FDA 510(k)
- Advisory Committee
- Orthopedic FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Quick-Start Orthopaedic Fixation Screw and Reverse Thread Screw is a metallic interference screw classified under the Orthopaedic Screw nomenclature. It is designed for graft fixation in ligament reconstruction procedures, including ACL, PCL, MCL, LCL, PLC, and MPFL surgeries. The device provides mechanical interference fixation to secure soft tissue or synthetic grafts within bone tunnels, ensuring stable integration during healing.
Implanted in an operating room setting by a surgeon, this screw is part of a cannulated system for precise placement. Supplied sterile and intended for single-use, it adheres to FDA 510(k) clearance and MDD regulatory standards. The device is available in sizes and configurations specified in the product documentation, with no noted MRI compatibility restrictions. Authorisations include FDA clearance under K242442 and compliance with the Medical Devices Directive.
Frequently asked questions
What types of ligament reconstruction surgeries is this screw designed for, and how does it function in those procedures?
This screw is specifically designed for graft fixation in ligament reconstruction surgeries, including ACL (anterior cruciate ligament), PCL (posterior cruciate ligament), MCL (medial collateral ligament), LCL (lateral collateral ligament), PLC (posterolateral corner), and MPFL (medial patellofemoral ligament). It provides mechanical interference fixation to secure soft tissue or synthetic grafts within bone tunnels, ensuring stable integration during the healing process. The screw is part of a cannulated system, allowing for precise placement in the operating room.
Is this device intended for reuse, or is it meant to be used only once? How is it supplied?
The Quick-Start Orthopaedic Fixation Screw is intended for single-use only and is supplied sterile to ensure patient safety and infection control. This aligns with standard practices for orthopaedic implants, where sterility and single-use minimize risks associated with repeated exposure to bodily fluids or contamination.
Are there any restrictions on using this screw in MRI scans after implantation?
The product documentation does not mention any MRI compatibility restrictions for this screw, meaning it may be safe for MRI imaging post-implantation. However, clinicians should always verify this with the manufacturer or consult the latest technical data sheets, as MRI safety can depend on specific models, materials, and imaging protocols.
How do I determine the correct size or configuration for this screw in a procedure?
The available sizes and configurations for this screw are detailed in the product documentation provided by Innovate Orthopaedics, Ltd. Since the exact dimensions are not listed here, clinicians should refer to the manufacturer’s specifications or consult with their surgical team to select the appropriate size based on the patient’s anatomy, graft type, and tunnel dimensions. The cannulated design aids in precise placement, but sizing remains critical for optimal fixation.
What regulatory pathways does this device follow, and how does that affect its use in clinical practice?
This device follows FDA 510(k) clearance (under K242442) and complies with the Medical Devices Directive (MDD). The FDA clearance indicates it is deemed *substantially equivalent* to a legally marketed predicate device, while MDD compliance ensures it meets EU safety and performance standards. Clinicians should confirm local regulatory requirements and manufacturer guidelines for proper use, as these pathways ensure the device’s safety and efficacy for its intended surgical applications.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Quick-Start Orthopaedic Fixation Screw and Reverse Thread Screw, Quick-Start Orthopaedic Fixation Screw and Reverse Thread Screw, quick-start orthopaedic fixation screw and reverse thread screw, Quick-Start Orthopaedic Fixation Screw and Reverse Thread Screw
Authorization Coverage (2 countries)
Regulatory Authorizations
MDD
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDD | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K242442 | Class II | Active |
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Manufacturer
- Manufacturer
- Innovate Orthopaedics, Ltd.
Sources (2)
- FDA 510(k) K242442 24 fields · synced Sep 18, 2026
- EUDAMED 1 fields · synced May 19, 2026